ACTion™ Block Pump, 1000ml, 5-15 ml/hr, Clamp 419111000

GUDID 05707480143856

ACTion Block 1000, 5-15 ml/hr (2 reservoirs for 1000 ml)

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480143856
• NIH Device Record Key: cd35c4bf-4c82-4b75-8600-e85aa9e0a6f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTion™ Block Pump, 1000ml, 5-15 ml/hr, Clamp
• Version Model Number: 419111000
• Catalog Number: 419111000
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480143849 [Primary]
GS1	05707480143856 [Package]; Contains: 05707480143849; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072053

FDA Product Code

• MEB: Pump, infusion, elastomeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-04
• Device Publish Date: 2020-08-27

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